Training & Events

Day 2:

Good Manufacturing Practices can be implemented in a variety of ways, with the responsibility falling on the company to select the best option for compliance. In order to make this choice, a higher level of understanding is required, not only of the regulations themselves but also of the expectations and intent of the GMP.

This advanced one-day session has been developed to support both a basic understanding of GMP with a more in- depth focus. This interactive session will incorporate case studies, “real world” scenarios, and hands on examples to help participants gain a more in depth understanding of GMP.

This material is geared towards those who have worked in GMP, are familiar with the basic expectations or who want to gain a more thorough understanding of the following more advanced topics.

• Introduction to investigations including Out of Specification results
• Recall Management
• Risk Assessments
• CAPA
• Change management
• Auditing
• Annual Product Quality Reviews
• Vendor management
• Current Global Regulatory Trends
• Inspection preparation

*Course attendees are encouraged to email examples of GMP concerns or challenges for group discussion and instructor feedback prior to class at nicole.schepp@compliantapproach.com

*All participants will receive package of course materials to keep, along with a certificate of completion. This course meets the regulatory requirements of annual GMP training.

 Interested in taking both classes.  Click here for more information on Basic GMP.  Purchase both sessions and save.